临床试验/NCT00582725

NCT00582725已完成2 期

Phase II Trial of Rituximab-CHOP (R-CHOP) Plus GM-CSF for Previously Untreated Diffuse Large Cell Lymphoma in the Elderly

University of Wisconsin, Madison1 个研究点分布在 1 个国家目标入组 38 人开始时间: 2002年3月最近更新: 2019年12月13日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: University of Wisconsin, Madison
入组人数: 38
试验地点: 1
主要终点: Response Rate to Therapy

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Patients will receive 6 to 8 cycles of R-CHOP (Rituximab, Cyclophosphamide, doxorubicin, vincristine, and prednisone), with GM-CSF.

详细描述

The objective of this study is to estimate complete response rates for patients treated with this regimen, to assess overall response rates, event-free survival and overall survival; and to assess toxicities associated with R-CHOP + GM-CSF. Patients will receive 6 to 8 cycles of R-CHOP (Rituximab, Cyclophosphamide, doxorubicin, vincristine, and prednisone), with GM-CSF.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 60 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Histologically confirmed, CD20+ B cell diffuse large cell lymphoma, with measurable or evaluable disease
•Having no prior chemotherapy, immunotherapy or radiotherapy except for one cycle of CHOP or R-CHOP.

排除标准

•Hepatitis B Surface Antigen positive
•Have known CNS disease or HIV infection
•Have NY Classification III or IV disease.

研究组 & 干预措施

R-CHOP + GM-CSF

Experimental

R-CHOP therapy (6-8 cycles) with GM-CSF

干预措施: R-CHOP+GM-CSF (Drug)

结局指标

主要结局

Response Rate to Therapy

时间窗: Dec 2005 approx

次要结局

未报告次要终点

研究者

发起方

University of Wisconsin, Madison

申办方类型

Other

责任方

Sponsor

研究点 (1)

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